Safety Alerts
The Food and Drug Administration (FDA) routinely publishes a variety of alerts related to the safety of medical devices, pharmaceuticals, biologics, vaccines, dietary supplements, and cosmetics.
The agency receives complaints and other safety-related information from health care providers, manufacturers, and consumers on its MedWatch program.
When the FDA deems it to be appropriate based on the severity of the issue, the volume of complaints, or other factors, it will issue a warning or safety alert to health care providers and the public.
Warnings and safety alerts can include:
- Product issues.
- Ancillary issues that can be a safety hazard, such as labeling.
- Recalls.
- Any other information related to a negative effect on the safety of a product.
Medical Devices and Pharma is focused on providing consumer information regarding medical devices and pharma, and we will report warnings and safety alerts for those products and any that are directly related to their safety.
Avanos Recalls Ballard Closed Suction Systems
May result in non-sterile devices Avanos Medical, Inc. is recalling its Ballard Closed Suction Systems after identifying a failure in the sterilization process, which may result in non-sterile devices. Use of these products could lead to serious health risks,...
FDA Alert: Abiomed Impella Blood Pump Controller
Abiomed Impella blood pump controllers Controller May Fail to Detect Device Abiomed has issued an urgent safety notice for its Automated Impella Controller (AIC) due to a potentially serious issue where the system may fail to detect the Impella blood pump when...
GE HealthCare Anesthesia Systems Recall Due to Ventilation Risk
GE Carestation Anesthesia Systems GE HealthCare has issued a high-priority correction for certain Carestation anesthesia systems due to a potentially life-threatening risk when used in Volume Control Ventilation (VCV) mode. Affected Devices Carestation 620, 650, 650c...
A Dangerous and Unapproved Drug Sold as a “Cure”
The dangers of tianeptine FDA warns that tianeptine is sold online and even at gas stations as a supposed treatment for depression, anxiety, pain, and opioid withdrawal. But don’t be fooled — this drug is not approved by the FDA for any medical use in the U.S. and has...
Beware of False “Cures” for Autism
Unapproved and Potentially Harmful Products Autism Spectrum Disorder (ASD) affects about 1 in 68 children, and while early behavioral therapies can help improve symptoms, there is no cure for autism. Unfortunately, some companies promote unproven products that falsely...
Formaldehyde in Hair Smoothing Products: Know the Risks
Know the Risks Before You Straighten Thinking of straightening or smoothing your hair? Many salon hair treatments release formaldehyde gas — a known human carcinogen — when heated. This chemical can pose serious short- and long-term health risks to both clients and...